Senior Validation Manager

6 days ago

Melbourne, Victoria, Australia beBeeValidation Full time $180,000 - $200,000
Job Description

The Process Validation Specialist is responsible for ensuring the operational qualification (OQ) of process equipment, guaranteeing that all processes meet industry standards and regulatory requirements.

This role involves leading Operational Qualification (OQ) activities for process equipment, focusing on filling and protein processing operations. Developing and reviewing OQ protocols and reports to ensure they meet regulatory requirements and company standards. Coordinating with cross-functional teams, including manufacturing, engineering, and quality assurance, to ensure successful OQ execution.

Key Responsibilities
  • Operational Qualification (OQ):
    • Lead Operational Qualification (OQ) activities for process equipment, focusing on filling and protein processing operations.
    • Develop and review OQ protocols and reports to ensure they meet regulatory requirements and company standards.
    • Coordinate with cross-functional teams to ensure successful OQ execution.
  • Process Equipment Validation:
    • Validate and qualify process equipment used in protein processing, fractionation, and bulk filling operations.
    • Ensure that all process equipment operates according to design specifications and is capable of consistently producing high-quality products.
    • Monitor and analyze equipment performance during OQ to identify and resolve any issues or deviations.
  • Protein Process Validation:
    • Oversee the validation of protein processing procedures, ensuring the robustness and reproducibility of processes that affect the product quality and stability.
    • Conduct risk assessments and identify critical process parameters (CPPs) and critical quality attributes (CQAs) specific to protein processing.
    • Collaborate with R&D and process development teams to integrate new protein processes into commercial production.
  • Fractionation & Bulk Filling:
    • Lead the validation of fractionation and bulk filling processes to ensure that they meet all quality and regulatory standards.
    • Develop and implement validation strategies for fractionation processes, including the separation and purification of protein products.
    • Validate bulk filling operations to ensure that final products are filled accurately and consistently, maintaining sterility and product integrity.
  • Documentation & Compliance:
    • Prepare, review, and maintain detailed validation documentation, including protocols, reports, risk assessments, and change controls.
    • Ensure that all validation activities comply with relevant regulations and industry standards.
    • Participate in audits and inspections by regulatory bodies, providing validation documentation and responding to inquiries.
  • Continuous Improvement:
    • Identify opportunities for process improvements based on validation data and trends.
    • Work with process engineers and production teams to implement changes that enhance process efficiency, product quality, and compliance.
    • Stay current with industry trends, regulatory updates, and best practices related to process validation and protein processing.

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